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CDC Microbiologist Reinstated After Raising Concerns About Agency's Zika Test

NEW YORK (GenomeWeb) – A microbiologist at the US Centers for Disease Control and Prevention who claimed to have received whistleblower retaliation after raising concerns that the agency promoted the use of an inadequately sensitive Zika virus test has been reinstated following an internal investigation.

According to a letter sent to the White House yesterday from the US Office of Special Counsel, CDC microbiologist Robert Lanciotti raised concerns that the CDC recommended its Trioplex real-time PCR-based assay that tests for Zika, dengue, and chikungunya, even though Lanciotti's evaluations found that the Singleplex test for Zika only could detect 39 percent more Zika infections.

The US Food and Drug Administration granted Emergency Use Authorization for the Trioplex assay, which was developed by the CDC, in March. The CDC-developed Singleplex test can also be run by state and local labs that are qualified to run the agency's West Nile assay or that have passed a proficiency panel.

Lanciotti, however, disagreed with the CDC's recommendation that public health laboratories use the Trioplex assay and first expressed his concerns internally in April. Lanciotti was reassigned to a non-supervisory position in his laboratory and subsequently filed a whistleblower retaliation claim with the US Office of Special Counsel, alleging that the demotion was because of his concerns with the Zika test. The OSC referred his claims and concerns with the Trioplex test to the US Department of Health and Human Services for investigation in July.

Lanciotti has since been reinstated as director of his lab. In addition, the Office of Special Counsel requested that the CDC investigate Lanciotti's concerns with the sensitivity of the Trioplex Zika test.

The CDC's investigation, however, did not substantiate Lanciotti's concerns. The CDC team evaluated three comparisons of the Trioplex and Singleplex assays, including the study by Lanciotti where he found the Singleplex assay was more sensitive.

"Ultimately the comparison data were limited and inconclusive; inconsistencies in how the assays were performed and in data reporting precluded making a statistically valid conclusion about the relative performance of the assays," according to the CDC's report to HHS and the OSC.

With regards to the comparison study performed by Lanciotti, the CDC investigators said that sensitivity differences could be attributed to the fact that Lanciotti used larger sample inputs for the Singleplex assay than for Trioplex and did not follow the protocols outlined in the EUA for the Trioplex assay. In a comparison study where researchers used the same input volumes and same RNA extraction protocols for both the Trioplex and Singleplex assay, there were no differences in sensitivity, according to the CDC researchers.

The CDC also noted that it is continuing to improve on the Trioplex assay and in August submitted an amendment to the EUA for Trioplex that would allow larger sample volumes.